By Mitul Agarwal, B.Pharm, MBA. Published 2 October 2026. Dates checked against company filings, FDA notices and launch announcements up to that day.
Short answer: in 2026 the US market opened to generics of dapagliflozin (Farxiga), sitagliptin (Januvia and Janumet), tofacitinib (Xeljanz), pomalidomide (Pomalyst), sugammadex (Bridion) and nintedanib (Ofev), and lenalidomide (Revlimid) generics lost their volume limits. In Europe, the key apixaban (Eliquis) patents and SPCs expire in November 2026. Semaglutide went generic in India on 21 March 2026, with Canada and Brazil approving generics soon after. Enzalutamide (Xtandi) is the next big US date, in August 2027.
This page is a reference for importers, distributors and generic manufacturers. It separates three things that are often mixed up: a generic that has actually launched, an entry date that is agreed or expected, and a patent expiry that may or may not let generics in. We'll update it as dates move.
Already launched in 2026
| Medicine (brand) | Therapy area | Market | What happened |
|---|---|---|---|
| Lenalidomide (Revlimid) | Myeloma | US | Generics had been sold under volume-limited settlement licences since 2022. The limits ended on 31 January 2026. |
| Pomalidomide (Pomalyst) | Myeloma | US | Generic entry in Q1 2026, as BMS had forecast. Natco and its partner Breckenridge launched in March. |
| Nintedanib (Ofev) | Lung fibrosis | US | Several generics approved in April 2026. Some newer indications stay protected until 2026–27, so generic labels may leave them out. |
| Dapagliflozin (Farxiga) | Diabetes, heart failure, kidney disease | US | FDA approved the first generics on 7 April 2026, for type 2 diabetes and heart-failure risk reduction in diabetes. Patents on other heart-failure and kidney uses run much longer. |
| Sitagliptin (Januvia, Janumet) | Diabetes | US | Settlement-based entry. Sandoz launched on 26 May 2026 and Apotex on 2 June. |
| Tofacitinib (Xeljanz) | Rheumatoid arthritis, ulcerative colitis | US | Hikma launched the oral solution on 3 June 2026 and Breckenridge the tablets on 4 June. |
| Sugammadex (Bridion) | Anaesthesia | US | Dr. Reddy's launched first-to-market vials on 29 July 2026; other companies followed. |
| Aflibercept 2 mg (Eylea) | Retina | US | Biocon launched its biosimilar Yesafili on 3 August 2026, the second Eylea biosimilar on the US market. |
| Omalizumab (Xolair) | Asthma, allergy | US | Celltrion's biosimilar Omlyclo was reported available from 1 September 2026. It was already sold in Europe from late 2025. |
Expected before the end of 2027
| Medicine (brand) | Market | Expected | Basis and caveats |
|---|---|---|---|
| Apixaban (Eliquis) | EU | November 2026 | BMS says the compound patents and SPCs expire in November 2026, and generics are already sold in some EU countries while court cases continue. In the US, settled generics can launch in 2028. |
| Aflibercept 2 mg (Eylea) | US | Q4 2026 | Further biosimilars are due under settlements with Regeneron, including Celltrion's by 31 December 2026. |
| Golimumab (Simponi) | US | Q4 2026 | FDA approved the first biosimilars (Immgolis) in May 2026; Accord plans to launch in Q4. In Europe, a biosimilar has been on sale since December 2025. |
| Edoxaban (Lixiana) | South Korea | November 2026 | Compound patent expires 10 November 2026; Korean generic makers are preparing to launch. |
| Sacubitril/valsartan (Entresto) | EU | Late 2026 to 2028, by country | US generics launched in 2025. In Europe, Novartis's regulatory protection ends in November 2026, but in August 2026 the UK High Court upheld a combination SPC that runs to 2028. Expect different dates in different countries. |
| Enzalutamide (Xtandi) | US | August 2027 | The compound patent expires on 13 August 2027, and at least one generic (Sandoz) is already FDA-approved. |
Patent dates to watch (not launch dates)
For these medicines we found patent expiry dates in 2026–27, but no confirmed generic launch date. Later patents, settlements or exclusivities can push entry back by years, so treat these as signals to start talking to manufacturers, not as launch dates.
- Vortioxetine (Trintellix): US compound patent, with paediatric extension, to December 2026. Other patents run to at least December 2027.
- Palbociclib (Ibrance): US compound patent with extension to March 2027, plus paediatric exclusivity to September 2027. Crystal-form patents run to 2034. Pfizer lists Europe as 2028.
- Olaparib (Lynparza): AstraZeneca lists a key US patent expiring in 2027 and Europe in 2029.
- Dolutegravir (Tivicay): US compound patent to October 2027. Most low- and middle-income countries already have generics through the Medicines Patent Pool.
- Macitentan (Opsumit): the US compound patent expired in December 2025 and several generics are approved; we could not confirm launch dates.
Outside the US and Europe: semaglutide leads
- India: the core semaglutide patent expired in March 2026, and Dr. Reddy's, Zydus, Alkem, Sun Pharma and Glenmark launched generics on 21 March.
- Canada: Health Canada approved its first generic semaglutide in April 2026 and a second in May, making Canada the first G7 country to do so.
- Brazil: Anvisa approved its first generic in May 2026 and five more on 29 July. Pharmacy sales were waiting for price approval.
- China: the compound patent expired in March 2026 and several local companies have filed. We could not confirm an approval.
- Japan: BMS lists Eliquis exclusivity in Japan as ending in 2026.
Semaglutide remains patented in the US and Europe into the 2030s, so generic semaglutide cannot be supplied there. Our guide, Semaglutide patent expiry by country, tracks where it is legal.
What this means if you import or manufacture
- A US or EU launch doesn't open your market by itself. Your regulator decides. Many now offer a fast route for products already approved by the FDA or EMA, and our import guides hub compares those routes for 45 countries.
- Check the patent position in your own country. Patents are national. A molecule can be generic in the US and still protected where you sell, or the reverse.
- Watch for carved-out indications. Dapagliflozin and nintedanib generics launched with labels that leave out some protected uses. Ask the manufacturer for the exact approved label, not just the molecule name.
- The first months are the tightest. Early generic supply often goes to the launch market first. If you plan to tender or register, start supplier conversations and dossier requests now.
If you need a GMP source for any of these molecules, with documents shared before you commit, send us an RFQ with the product, strength, quantity and destination.
How we checked
- Launch dates come from company press releases and FDA notices. Patent and exclusivity dates come from the originators' own filings (BMS, Merck, Pfizer, AstraZeneca annual reports).
- Where sources disagreed, we say so in the table. Where we found only a patent date, we list it separately and don't call it a launch.
- Nothing here is legal advice. Patent status should be confirmed by a patent attorney for your specific market before you commit to a launch.
Sources
- Bristol Myers Squibb, 2025 Form 10-K (Eliquis, Pomalyst, Revlimid)
- Merck & Co., 2025 Form 10-K (Januvia, Janumet, Bridion)
- Pfizer, 2025 annual report (Xeljanz, Ibrance, Xtandi)
- AstraZeneca, patent expiries of key marketed products 2025
- FDA approves first generic Farxiga (Drugs.com, 7 April 2026)
- Generics for Januvia, Janumet and Xeljanz hit the market (myMatrixx)
- Dr. Reddy's sugammadex launch (Business Wire, 29 July 2026)
- Breckenridge pomalidomide launch
- Biocon Yesafili US launch
- Health Canada: second generic semaglutide approved
- Generic semaglutide launches in India (Pearce IP via Lexology)
- Brazil clears five semaglutide generics (TechTimes, 29 July 2026)
- Edoxaban patent expiry in Korea (Korea Biomedical Review)
- FDA approves Immgolis, first Simponi biosimilars (Accord BioPharma)
Next update: January 2027.
Frequently Asked Questions(FAQs)
Is generic Eliquis (apixaban) available?
In parts of Europe, yes: generics are already sold in some EU countries, and the main patents and SPCs expire in November 2026. In the US, settled generics can launch in 2028.
When did generic Farxiga (dapagliflozin) launch in the US?
FDA approved the first generics on 7 April 2026, and launches followed that month.
Is generic semaglutide legal?
In India, yes, since 21 March 2026, and generics have been approved in Canada and Brazil. It is still patented in the US and Europe.
What is the next big generic launch in the US?
Of the dates we could confirm, the biggest in 2027 is enzalutamide (Xtandi), whose US compound patent expires in August 2027.
